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MONO'x

by Biosintex SRL 48 variants

Ref BX913Model Poly(glycolide-co-caprolactone) (75/25) monofilament absorbable sterile surgical suture

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05944756519018 Basic UDI-DI 05944756519018UDI-DIDate4 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
Poly(glycolide-co-caprolactone) (75/25) monofilament absorbable sterile surgical suture, BX913
Primary DI / UDI-DI
05944756519018
Basic UDI-DI
B-05944756519018
EMDN Code
H010101010302 Poliglecaprone and derivatives monofilament without needle
Device Class
Class III
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000001463

Other devices from Biosintex SRL

See all devices from Biosintex SRL →

Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No